Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia

Functional Endoscopic Sinus Surgery Clinical Trial

Official title:

Comparison Between Single Dose Pregabalin and Magnesium Sulfate in Controlled Hypotension During Functional Endoscopic Sinus Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442931
• Other study ID #: 55:2021
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: June 2022
• Source: Minia University
• Contact: Eman Gamal, MD
• Phone: 01032862852
• Email: emangamalhassan2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between pregabalin and magnesium sulfate in hypotensive anaethesia

Description:

compare the effect of a single-dose 150 mg oral pregabalin and 2 grams intravenous magnesium sulfate given 30 minutes before induction of anesthesia on the total nitroglycerine used in patients undergoing functional endoscopic sinus surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA: class 1 or 2

• Sex: male and female

• Age: from 18 to 70 years

• Patients scheduled for functional endoscopic sinus surgery

Exclusion Criteria:

• Patient on diuretics, corticosteroid, pregabalin

• Patients with a history of allergy to the study drug

• Pregnancy or breastfeeding women Patients with hypertension, cardiac, renal endocrinal diseases

• uncooperative patients (cant does not administer oral tablet)

Related Conditions & MeSH terms

• Functional Endoscopic Sinus Surgery

Intervention

Drug:
• Pregabalin 150mg
The oral tablet half an hour preoperative 150 milligrams
• Magnesium Sulfate
Intravenous administration half an hour preoperative 2 grams
• Nitroglycerin
measure total dose of nitroglycerine in milligrams using a syringe pump

Other:
• surgeon satisfaction
surgeon satisfaction measured according to Likert's scale

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of nitroglycerine	total dose measured by a syringe pump	an hour and half
Secondary	quality of surgical field	using Boezaart et al grading scale	an hour and half
Secondary	surgeon satisfaction	using Likert's scale	an hour and half